Mindlance
Location
Remote
Top Skills, Experience, and Education
SAS Programming
Develop, validate, and maintain clinical safety datasets.
SDTM, ADaM, and CDISC Standards
Build and support integrated ADaM and SDTM datasets.
Ensure compliance with FDA and EMEA regulatory expectations.
IB, DSUR, PSUR, ISS, Client, Study CSR Work
Lead data integration and support safety reporting deliverables.
CDISC Data Standards Understanding
Apply CDISC specifications to dataset creation and validation.
Communication and Team Collaboration
Excellent verbal and written communication skills.
Collaborate with statisticians, data managers, and pharmacovigilance stakeholders.
Purpose This role leads the statistical programming activities for development and maintenance of integrated clinical safety datasets for one or more compounds, indications, or therapeutic areas. The responsibilities include interfacing with Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing, and Clinical Operations teams.
Responsibilities
Apply in-depth knowledge of CDISC Standards, SAS programming concepts, and pharmaceutical industry techniques.
Lead compound-level data integration to create pooled ADaM datasets across multiple studies and indications.
Develop and validate ADaM specifications and SAS programs supporting ISS/Client ADaM programming and regulatory submissions.
Create and validate SDTM, ADaM, and TLFs for CSR, ISS, and Client following SOPs, departmental, and project standards.
Support IB, DSUR, and annual safety reporting deliverables.
Adopt internal macros, processes, and programming environments quickly.
Work collaboratively with stat programmers, statisticians, data management personnel, and Pharmacovigilance stakeholders.
Ensure accurate derivations as defined by the protocol and statistical analysis plan.
Maintain internal consistency of outputs and reconcile pooled, ISS, and study data as needed.
Interpret statistical analysis plans to develop analysis dataset specifications.
Implement client process improvements.
Respond to client requests promptly and with urgency.
Comply with training requirements.
Qualifications
BS or MS in Statistics, Computer Science, or a related field with at least 8 years of SAS programming experience in the pharmaceutical or related industry.
Extensive clinical trial experience with familiarity with FDA and EMEA regulatory expectations.
Expert working experience in SDTM and ADaM dataset creation and validation.
High technical competence and excellent oral and written communication skills.
Demonstrated competency and hands‑on experience in SAS programming, macro, and utilities development.
EEO Statement Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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Remote
Top Skills, Experience, and Education
SAS Programming
Develop, validate, and maintain clinical safety datasets.
SDTM, ADaM, and CDISC Standards
Build and support integrated ADaM and SDTM datasets.
Ensure compliance with FDA and EMEA regulatory expectations.
IB, DSUR, PSUR, ISS, Client, Study CSR Work
Lead data integration and support safety reporting deliverables.
CDISC Data Standards Understanding
Apply CDISC specifications to dataset creation and validation.
Communication and Team Collaboration
Excellent verbal and written communication skills.
Collaborate with statisticians, data managers, and pharmacovigilance stakeholders.
Purpose This role leads the statistical programming activities for development and maintenance of integrated clinical safety datasets for one or more compounds, indications, or therapeutic areas. The responsibilities include interfacing with Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing, and Clinical Operations teams.
Responsibilities
Apply in-depth knowledge of CDISC Standards, SAS programming concepts, and pharmaceutical industry techniques.
Lead compound-level data integration to create pooled ADaM datasets across multiple studies and indications.
Develop and validate ADaM specifications and SAS programs supporting ISS/Client ADaM programming and regulatory submissions.
Create and validate SDTM, ADaM, and TLFs for CSR, ISS, and Client following SOPs, departmental, and project standards.
Support IB, DSUR, and annual safety reporting deliverables.
Adopt internal macros, processes, and programming environments quickly.
Work collaboratively with stat programmers, statisticians, data management personnel, and Pharmacovigilance stakeholders.
Ensure accurate derivations as defined by the protocol and statistical analysis plan.
Maintain internal consistency of outputs and reconcile pooled, ISS, and study data as needed.
Interpret statistical analysis plans to develop analysis dataset specifications.
Implement client process improvements.
Respond to client requests promptly and with urgency.
Comply with training requirements.
Qualifications
BS or MS in Statistics, Computer Science, or a related field with at least 8 years of SAS programming experience in the pharmaceutical or related industry.
Extensive clinical trial experience with familiarity with FDA and EMEA regulatory expectations.
Expert working experience in SDTM and ADaM dataset creation and validation.
High technical competence and excellent oral and written communication skills.
Demonstrated competency and hands‑on experience in SAS programming, macro, and utilities development.
EEO Statement Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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